Role of adaptive randomization in developing novel therapies for patients with breast cancer

The rapidly expanding number of new, molecularly-targeted treatments for patients with breast cancer has dramatically increased the pressure to evaluate safety and efficacy for these compounds in a more efficient fashion (1). Moving quickly from early phase, proof-of-mechanism studies to more definitive therapeutic trials has become an important focus of cancer drug development efforts over the past decade (2). New clinical trial designs that explore testing of several new agents simultaneously in a single “umbrella” or “basket” study are currently being explored as a means to this end (3).